CMOs roll out expansions

Contract manufacturing organizations (CMOs) are investing in Asia, with several recent announcement on expansions there. Also, several companies add capabilities in sterile manufacturing and formulation.

Global positioning

The CMO (Basel, Switzerland) and the biocatalysis specialist (Redwood City, CA) recently expanded in Asia. Lonza announced last month the start-up of its small-scale plant for active pharmaceutical ingredients (APIs) and intermediates in Nansha Guangzhou, China. The Nansha facility, which operates under current good manufacturing practices, is designed to produce quantities from 10 kg up to several hundreds of kilograms. Lonza is also building a commercial-scale API facility in Nansha. That facility is scheduled to go on line in the second half of 2008.

Codexis opened up a new 20,000-ft² research and development center in Singapore in late October. The facility is the company's first in Asia and will support both innovator and generic drug companies.

In a transatlantic move, (Craigavon, Northern Ireland) announced in October plans to invest £50 million ($104 million) to establish a new North American headquarters facility in southeast Pennsylvannia. Almac's expansion project will be competed in several phases. Initially, the company will construct a 240,000-ft² building in Lower Salford Township and combine its two Pennsylvania divisions located in Audubon, Montgomery County, and Yardley, Bucks County. Construction is scheduled to begin in 2008 with the facility expected to be fully operationally in 2010.

Almac Group consists of five businesses: Almac Diagnostics, Almac Clinical Services, Almac Clinical Technologies, Almac Sciences, and Almac Pharma Services. Almac Sciences provides contract API manufacturing and related services, and Almac Pharma Services offers contract formulation services. Almac recently invested $10 million to expand its formulation services for solid oral dosage forms from preclinical through to pilot scale.

In another example of a sale of Western manufacturing assets to Indian CMOs and pharmaceutical companies, the Swiss CMO (Zofingen, Switzerland) sold is its subsidiary Siegfried Biologics to Avestha Biotherapeutics and Research (ABRPL), a joint venture between (Bangalore, India)and Meditab Specialities, part of (Mumbai, India). The companies announced the deal last month. Sigfried Biologics provides contract biologics manufacturing services with a manufacturing facility in Berlin, Germany. ABRPL plans to manufacture biopharmaeuticals for global markets with a focus on markets in Brazil, Russia, India, and China. The facility gained through the Siegfried acquisition will initially focus on biopharmaceuticals that are under development at Avesthagen through the Avesthagen-Cipla joint-venture agreement signed in May 2004.

Sterile manufacturing

(Parsippany, NJ) is adding aseptic fill-finish manufacturing services for injectable cytotoxic products. The facility will be ready for commercial production in January 2008. The company's aseptic cytotoxic capabilities include commercial-scale fill-finish services for liquid and lyophilized products in vial sizes as much as 65 mL. The dedicated suites use restricited access barrier systems to ensure product isolation and include a TL filler and a freeze dryer.

"The market for injectable cytotoxic products is expected to grow at double-digit levels over the next five years as evidenced by the number of customers interested in our cytotoxic capabilities," said Terry Novak, president of DSM Pharmaceuticals Inc., in a company release.

Addressing the need to add anti-counterfeiting functionality to prefilled syringes, (Ravensburg, Germany) launched a new tamper-evident closure system with a needle shield for prefilled syringes. Vetter launched the new system, "V-OVS NS," at CPhI/ISCE, held in Milan, last month.

The V-OVS NS fits on a glass barrel syringe. It consists of a sealing ring and protective cap with a needle protection element of soft rubber. Removing the cap breaks the seal, indicating that the syringe had been tampered with or used.

"The new closure system is a validated system, making it easy for a pharmaceutical company to adapt the product," explains Tilman Roedle, head of packaging development services at Vetter.

The market for prefilled syringes is expected to grow by 12.8% per year, according to industry estimates. In 2006, about 1.4 billion prefilled syringes were sold, and by 2010 the quantity is expected to top 2.4 billion (1).

Vetter is a leading specialist in the production of aseptically prefilled injection systems (syringes, cartridges and vials.) The company manufactures the products at is facilities in Ravensburg and Langenargen, Germany.

References

1. M. Rios and B. Harrison, "Big Shot: Development of Prefilled Syringes," Pharm. Technol. 31 (3), 50–56 (2007).